Implementation of pharmacovigilance in current healthcare conditions: focus on spontaneous reports
Abstract
This article is dedicated to the relevance for modern healthcare of the development and strengthening of the pharmacovigilance system — the science and practice of monitoring the safety of drugs. The paper highlights the importance of post-registration studies for identifying rare, delayed, including serious, adverse events, and also examines the main methods and tools of pharmacovigilance, such as spontaneous reports, cohort monitoring, active surveillance, prescription analysis, and literature meta-analyses. This article discusses the complexities and limitations of existing methods, the need to improve awareness among healthcare personnel, and the expansion of active approaches to data collection in both inpatient and outpatient settings.
Fields of Study & Subjects
Pharmacovigilance and Adverse Drug Reactions
Pharmaceutical industry and healthcare
Data-Driven Disease Surveillance
Publication details
- Journal / source
- Glavvrač (Chief Medical Officer)
- Issue
- 1
- Pages
- 17–29
- Publication date
- 30 January 2026
- Language
- EN